Events

Simulation from ODE-based population PK/PD and systems pharmacology models in R using mrgsolve

June

06

2017


Tues, June 6, 2017
8:30 AM – 4:30 PM CEST
Budapest Congress Centre
Jagelló út 1-3
Budapest, Hungary

Summary

After a brief review of simulation principles and planning strategies, we will provide a guided hands-on experience in the use of the R package mrgsolve. mrgsolve is a free, open source, validated R package to facilitate simulation from hierarchical, ODE-based PK/PD and systems pharmacology models frequently employed in pharmaceutical research and development programs. You will code, execute, and summarize PK, PK/PD and systems pharmacology model simulations using mrgsolve and R. T hrough many examples, you will learn to implement model-based simulations to help address questions at a variety of stages of a development program.

Workshop Outline

  • Hands-on Introduction to mrgsolve
    • Installation overview
      • Where to get mrgsolve
      • R and toolchain requirements
      • Other required R packages
  • Basic introduction to mrgsolve
    • Code a very basic model
    • Code and work with model object
    • Basic simulation with event object
    • Basic handling of simulated output
    • Models with covariates and population elements
    • Updating the model object; sensitivity analyses with mrgsolve
  • Monte-Carlo simulation from PK/PD models
    • Fixed effect simulation from posterior parameter distributions
      • Parallelizing simulations in R
      • Run and summarize the fixed effect simulation
    • Population PK/PD simulation from posterior parameter distributions
      • Preparing estimation model output for use with mrgsolve
      • Run and summarize the population simulation
      • Calculate probability of technical success through simulation
      • Example: Simulated bioequivalence trials in the presence of inter-occasion variability in clearance
      • Example: Monte Carlo simulation from systems pharmacology model
  • Discussion and summary

Course will be led by Metrum's Matthew Riggs, Ph.D. and Rena J. Eudy-Byrne, Ph.D.

Register Here